Topic

R.D. McDowall is principal of McDowall Consulting and director of R.D. McDowall Limited, and "Questions of Quality" column editor for 

Articles

It is traceability that shows that the ALCOA criteria does not exist in individual silos, but that they all interact with and are dependent upon each other.

Is Traceability the Glue for ALCOA, ALCOA+, or ALCOA++?

Computerized system validation (CSV) has an uninspiring reputation for
being a slow, no-value-added activity that only wastes time and delays the
implementation of new software. Is that an accurate portrayal? And is it a
necessary evil?

Does CSA Mean  “Complete Stupidity Assured?”

In this column, Bob McDowall discusses the impact of USP general chapter 1058 on the spectroscopy laboratory.

USP <1058> Analytical Instrument Qualification and the Laboratory Impact

The second part of this column series on traceability matrices looks at some of the practical ways of tracing requirements from the user requirements throughout the life cycle documents.

Validation of Spectrometry Software: The Proactive Use of a Traceability Matrix in Spectrometry Software Validation, Part II: Practice

Tracing requirements from a user requirements specification throughout the life cycle is not only a very effective business tool to save time and effort in validation projects but also a regulatory expectation. This first installment of a two-part column series looks at the principles of a traceability matrix.

Validation of Spectrometry Software: The Proactive Use of a Traceability Matrix in Spectrometry Software Validation, Part I: Principles

Columnist Bob McDowall discusses the role of a validation master plan (VMP) for summarizing a laboratory's approach to computer validation.

Validation of Spectrometry Software: Understanding the Role and Content of a Validation Master Plan

Columnist Bob McDowall discusses operating system security patches.

Validation of Spectrometry Software - To Patch or Not To Patch - That Is the Question

Part IV of this four-part series wraps up the discussion of mass calibration, covering the "new generation" attributes that have become apparent as researchers aim to meet the calibration demands of proteomics.

Analytical Method Validation